Just before the Olympic Games in Paris started, a not welcomed guest has made an appearance. The widely used chemical bisphenol A (BPA), a substance known to interfere with the hormone system, has been found in reusable children’s bottles with the Olympic logo, in levels exceeding the permitted limits for food contact materials. The products therefore had to be recalled, BBC reports, to minimise the risks posed by BPA to people exposed to the substance, such as breast cancer and infertility. Read below, why we still find bisphenols all around us despite knowing about their harm for ages.
The manmade chemical bisphenol A (BPA) is popular and widely used, mainly to produce plastics, which we find e.g. in food contact materials such as reusable water bottles or can linings. It was marketed already in 1934 as a pharmaceutical substance due to its similar effects to oestrogens, the female sex hormones. Its hormone system impacting properties have been known for decades. Substances with this kind of effects are called endocrine disruptors (ED), meaning that while being foreign to the body, they can interfere with the hormonal system and thereby affect the health of the organism or its offspring.
Despite early warnings on its risks, the regulation of BPA and other substances of the same group of bisphenols is still pending.
Bisphenols in our lives
The chemical BPA is part of a group of 200 similar chemicals called bisphenols, 34 of which are known or suspected of interfering with the hormonal and reproductive systems, and therefore should be banned1. The main uses of BPA are in the production of the polymers polycarbonates and epoxy resin which still contain BPA residues in the final material. Polycarbonate is used in many sectors e.g. electrical and electronic equipment (e.g. hairdryers), construction (e.g. road signs), and bottles and packaging (e.g. reusable bottles). Other structurally-chemically similar bisphenols are assumed to be already used or potentially usable in similar functions as BPA.
Humans are exposed to bisphenols as consumers, workers and via the environment with a number of significant adverse impacts for human health (see Figure 1). The main routes of exposure are orally through drinking water and food, which both get contaminated by packaging, as well as foetuses already via the placenta2. Another relevant exposure route for retail workers is the dermal uptake from bisphenols being used in thermal paper. Although BPA is banned for this specific use since 2020 in the EU, regrettably, other dangerous bisphenols have substituted BPA. House dust and microplastics are examples of additional sources of exposure.
Need for speed on BPA
Despite the growing scientific evidence on BPA impacts, authorities responsible for chemical regulation only took first actions on BPA in 2003 when hazards of BPA were further assessed. It took however another nine years until in 2012 BPA was listed and thus prioritised to undergo the substance evaluation process under REACH. Also, the following steps for substances with problematic properties, such as the harmonised classification (here as potentially damaging fertility – Repr. 1B) and the identification as substance of very high concern (SVHC) came much too late. EEB’s need for speed report4 picked up BPA as a case study for exemplary slow progress on the regulation of most harmful chemicals despite evidence of harm.
Having negative effects on reproduction was also confirmed for more members of the bisphenol group (e.g. BPS and BPAF). In 2018 the European Chemicals Agency recommended to add BPA to the ’Annex XIV’ of REACH after which its use would have been banned from the EU, unless companies ask for an authorisation.5 The various member states supported this recommendation6, but there was no follow up. The European Commission, responsible for the final decision, has been the main blocker.
Highlights of the timelines regarding the case of BPA are summarised in Figure 2
A patchwork of actions – Authorities in for a penny, also in for a pound?
Due to its harmful properties to human health and the environment, bisphenols were also taken up in the restrictions roadmap, the EU’s plan for banning the most hazardous substances under REACH. Following a restriction of the use of BPA in thermal paper proposed by France in 2013, the German Umweltbundesamt presented in 2022 a restriction proposal for BPA and other structurally related bisphenols that share the concern of endocrine disruption to the environment. After passing the completeness check by the expert committees in ECHA a public consultation on the dossier followed. According to the rules on the functioning of the committees, about a year after the submission of a restriction dossier, the scientific committees should have developed their opinions, so roughly about now. The process however never got to that point, since the proposal was withdrawn a few months after the public consultation ended without clear explanation and before the committees ever gave a first opinion. The file is still in the hands of German authorities and is not expected to be resubmitted before end of 20258 – if at all. Despite the severe concern of ED for human health of bisphenols being also highlighted in the restrictions roadmap9, there are no signs of further action being initiated by either another member state or the EU Commission, who initially committed to develop a complementary restriction.
With regard to food safety specifically, the European Food Safety Authority (EFSA), responsible for protecting consumers from pollutants through food, took separate action and updated in 2023 its previous preliminary opinion on the safe levels for uptake of BPA. Above the recommended ‘tolerable daily intake’ of bisphenols, adverse effects to human health could not be ruled out. Strikingly, the new limit value proposed by EFSA is 20 000 times lower than the previous standard.10 The concern over the health effects of bisphenols ingested via food yet remains high as EU citizens are currently exposed to levels far exceeding these new recommended limits.11
The EFSA opinion was followed in June this year by an EU wide ban of BPA in food contact material – an important exposure route for humans – which will enter into force at the end of 2024. This ban will concern mostly BPA in packaging, such as the coatings in metal cans, but also apply to some consumer articles such as reusable plastic drink bottles. A small glimmer of hope!
NGOs demand a swift continuation of regulatory action on Bisphenols, including human health and environmental concerns and believe that member states, the EU Commission and ECHA need to join forces and do everything in their power to keep up with the ambitions and priorities set out in the restrictions roadmap. This action shall include also a much broader scope than what the German restriction proposes, i.e. including the more than 30 bisphenols proposed by ECHA and member states to be regulated due to their potential endocrine disrupting or reprotoxic effects12.
Footnotes:
1 ECHA (2021). Assessment of regulatory needs. Group Name: Bisphenols https://echa.europa.eu/documents/10162/3448017/GMT_109_Bisphenols_Report_public_23502_en.pdf/1bd5525c-432c-495d-9dab-d7806bf34312?t=1647590013566 (last visited 29.07.2024)
2HBM4EU (2022). Substance report, Bisphenols, (https://www.hbm4eu.eu/wp-content/uploads/2022/07/Bisphenols_Substance-report.pdf) [no longer accessible]. See therefore EEA (2023) Human exposure to Bisphenol A in Europe https://www.eea.europa.eu/publications/peoples-exposure-to-bisphenol-a (last visited 29.07.2024)
3 HBM4EU (2022). Policy Brief Bisphenol, (https://www.hbm4eu.eu/result/policy-briefs/) no longer accessible. See therefore EEA (2023) Human exposure to Bisphenol A in Europe https://www.eea.europa.eu/publications/peoples-exposure-to-bisphenol-a (last visited 29.07.2024).
4 EEB (2023). The Need For Speed – Why it takes the EU a decade to control harmful chemicals and how to secure more rapid protections – https://eeb.org/library/the-need-for-speed-why-it-takes-the-eu-a-decade-to-control-harmful-chemicals-and-how-to-secure-more-rapid-protections/
5 ECHA (2018). Draft background document for 4,4′-isopropylidenediphenol (bisphenol A, BPA) https://echa.europa.eu/documents/10162/459e54a5-7035-254b-b10c-bc1b5b883ec1
6 MSC (2019). OPINION OF THE MEMBER STATE COMMITTEE ON THE DRAFT NINTH RECOMMENDATION OF THE PRIORITY SUBSTANCES TO BE INCLUDED IN ANNEX XIV OF THE REACH REGULATION AND THE ASSOCIATED ANNEX XIV ENTRIES – 26 June 2019. https://echa.europa.eu/documents/10162/17087/msc_opinion_and_supdoc_9th_draft_rec_annex_xiv_26062019_adopted.pdf/449547a9-9f43-2355-2195-084378139111?t=1569579458753
7 The Need For Speed – Why it takes the EU a decade to control harmful chemicals and how to secure more rapid protections – https://eeb.org/library/the-need-for-speed-why-it-takes-the-eu-a-decade-to-control-harmful-chemicals-and-how-to-secure-more-rapid-protections/
8 German REACH Helpdesk (2023) Beschränkung von Bisphenol A und verwandten Bisphenolen mit ähnlicher Besorgnis für die Umwelt https://www.reach-clp-biozid-helpdesk.de/DE/REACH/Verfahren/Beschraenkungsverfahren/Deutsche_Vorschlaege/BPA/BPA.html (last visited 29.07.2024)
9 ‘COM could request ECHA to prepare a restriction dossier that may complement the restriction of some bisphenols for environmental risks (pool 0, entry 4) due to concerns for human health as well as to cover additional bisphenols.’ Restrictions roadmap, pool 1, entry 7
10 EFSA (2023). Re‐evaluation of the risks to public health related to the presence of bisphenol A (BPA) in foodstuffs. https://www.efsa.europa.eu/en/efsajournal/pub/6857
11 EEA (2023) Human exposure to Bisphenol A in Europe https://www.eea.europa.eu/publications/peoples-exposure-to-bisphenol-a (last visited 29.07.2024)
12 ECHA, 2022b, ‘Group assessment of bisphenols identifies need for restriction’, European Chemicals Agency, (https://echa.europa.eu/da/-/group-assessment-of-bisphenols-identifies-need-for-restriction) accessed 26 July 2024.
